| Objective:To study and manufacture a kind of generational biomedical duralsubstitute material with decompressive and antimicrobial nature and its its physical properties,drug release in vitro,bacteriostasis,security and the role of prevention of infection in vivo to provide a theoretical basis for the new material clinical application and loading the sustained-release antibiotic to the intracranial substitute material.And to study the clinical efficacy of prevention and treatment of postoperative intracranial infection of the brain injury by traditional Chinese and western medicine therapy.Methods:1,Through performing tension,hysteresis and stress relaxation experiments of the 10 pieces of anti-infection artificial dura mater and analyzing the data obtained by the statistical analysis;2,Soaking the 10 pieces of 1cm×1cm biological material artificial dura mater in the 10 measuring-glasses with 100ml Sodium Chloride and puting them in 4℃refrigerator and close tightly,Then taking 1.0mL at intermittent times to determine it respectively by HPLC,and analyzing the data obtained by the statistical analysis;3,through observing and measuring the size of inhibition zone diameter of Staphylococcus aureus and Enterococcus faecalis at intermittent times respectively by puting 10 pieces of a diameter 6mm vancomycin-artificial dura materials and the same size and number of vancomycin-standard patch in the nutrition agar plate,then analyzing the data obtained by the statistical processing;4,To desigin and establish an animal model of duralplasty cerebral infection,forty-eight New Zealand rabbits were equally and randomly divided into 4 groups,ie,control group 1,experimental group1,control group2,experimental group2.Then,the dural defect of control group1 and control group2 was repaired with artificial duralsubstitute,The dural defect of experimental group1 and experimental group2 was repaired with vancomycin-artificial duralsubstitute,immediately after the operation, 1×10~7CFU of(MRSA)SAU3892 was injected into intracal in the control group 1, experimental group1 and 1×10~8CFU of(MRSA)SAU3892 was injected into intracal in the control group2,experimental group2,macroscopical examination after the operation,and the erythrocy sedimentation rate and WBC counts were measured before the operation,then measured 1,3,and 7 days after the operation.All the rabbits were sacrificed 7 days later,then pathological changes,bacteria cultures and morphological changes,then analyzing the data obtained by the statistical processing.5,The 54 cases of postoperative intracranial infection of the brain injury are randomly divided into two groups:the observation group 27 cases and the control group 27 cases by the random number table method.The observation group will be treated by the conventional therapy and the traditional Chinese and western medicine therapy,and then the control group simply by the conventional therapy,The both groups are treated for 30 days in order to study the clinical efficacy of the two groups.Results:1,The stress empirical datum statistical analysis result shows that the pressure -volume shows the good linear relationship in the new dura mater internal stress permission's scope;The new dura mater has the hysteresis as well as the flaccid phenomenonthe under the periodic load;2,The time-concentration curve of 10 patches displays the slow-up grading tendency before 5 days then the the horizontal tendency on the whole after 5 days;In vitro,the medicine slow release empirical datum statistical analysis result shows that time-concentration curve of each square centimeter vancomycin-artificial dura mater displays the linear relationship;3,The bacteriostasis experimental result demonstrats in vitro that the bacteriostasis circle diameter of the vancomycin-artificial dura mater material with the 6mm diameter reduces gradually along with the time expanding in 5 days,and 5 days later the bacteriostasis circle is not seen,and the obvious bacteriostasis circle of the standard diaphragm is seen only in the 1st day; 4,The test results revealed that the infection incidences were respectively control group 1 75.0%(9/12),experimental groupt 16.70%(2/12),control group2 100%(12/12),experimental group2 16.7%(2/12).5,After the both groups are treated for 30 days,there are two death cases in the observation group,and two death cases in the control group,too.The number of the cured cases in the observation group is 23 cases unless the 2 cases,and the number of the cured cases in the control group is 17 cases unless the 8 cases.By the comparison of the cure rate of the two groups,the clinical efficacy of the two groups is a significant difference(P＜0.05).Conclusion:1,The new kind of generational biomedical duralsubstitute material with decompressive and antimicrobial nature has a good compliance and elasticity;2,The average releasing-time of the new artificial dura of 1.0cm~2 in vitro is 5 days.The average dosage is 233.51μg.The rage of dosage is 209.66μg—257.36μg;3,The average releasing-time of the new artificial dura in vitro is 5 days,And the measured results by HPLC is 5 days,too.The vancomycin is sensitive against Staphylococcus aureus and Enterococcus faecalis;4,An animal model of duraplasty cerebral infection can be established successfully when 1×10~8CFU of(MRSA)SAU3892 was immediately injected into Intracalvarium after the operation.The new material:vancomycin -artificial dura mater is effective in preventing Intracalvarium from Staphylococcus aureus infection and the security is good.5,The Chinese and western medicine therapy is very effective for prevention and treatment of postoperative intracranial infection of the brain injury and controls the occurrence of postoperative intracranial infection to reduce the rate of the postoperative intracranial infection and promote the brain function recovery and reduce complications,the clinical efficacy is superior to the treatment of the conventional Western medicine alone. |
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